Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
(2000; 31 pages) View the PDF document
Table of Contents
Open this folder and view contents1. Introduction
Open this folder and view contents3. General basis for regulatory assessment
Close this folder4. Collection and regulatory assessment of evidence for medicinal products intended for self-medication
View the document4.1 Assessment of new active substances not marketed as prescription medicines and designed specifically for use in self-medication
View the document4.2 Assessment for self-medication of medicinal products hitherto available only on prescription
View the document4.3 Assessment of existing self-medication products that have not previously been evaluated
View the document4.4 Assessment of new strengths, formulations, doses, indications or combinations
View the documentAnnex
View the documentAcknowledgements
 

4.2 Assessment for self-medication of medicinal products hitherto available only on prescription

From previous sections it is clear that the evidence for or against the proposed use of a medicine in self-medication may be obtained from many different sources worldwide and analysed in a manner somewhat different to the material normally presented when a new pharmaceutical product is submitted for official approval by a national regulatory authority. The object should be to form an opinion on the basis of selected evidence. The material will generally comprise:

(1) The original regulatory data (chemistry, manufacturing, pharmaceutical, pharmacological, toxicological, clinical pharmacological and clinical trial data, and data on therapeutic efficacy and safety):

Much of this will be relevant only if the product as currently proposed for self-medication is in all respects identical to the original product. Human data will weigh much more heavily than animal data. If any of the original animal investigations suggested severe risks (e.g. carcinogenicity), the risks should be reassessed in the light of subsequent experience in humans.

(2) Clinical data obtained after the approval of the drug:

Trials performed according to current standards and relating closely to the proposed use in self-medication should be accorded the greatest weight.

(3) Drug utilization and consumption data:

These can be helpful in determining the way in which the medicinal product has hitherto been employed by physicians (volume of use, major indications in practice, precautions normally taken), and particularly in interpreting alleged risks.

(4) Reported adverse events/reactions and interactions:

These should be examined with respect to their profile, frequency and severity. Sources in which the evidence is critically assessed (especially in well-controlled clinical studies or epidemiological studies) are preferable to those in which unevaluated observations of possible adverse reactions are accumulated. Data from sources that have collected adverse drug reaction data from different countries for long periods of time may be useful, in particular, information from WHO’S International Drug Monitoring Programme Telephone: +46 18 656060, Facsimile: +46 18 656080. (Uppsala, Sweden).

(5) Current scientific data:

The pharmaceutical form and packaging should be considered; any available clinical studies, field data and market-related studies on consumer use of the product for self-medication should be examined.

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